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Home » Expediting the clinical trials process to advance brain tumor research
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Expediting the clinical trials process to advance brain tumor research

Paul E.By Paul E.September 21, 2024No Comments2 Mins Read
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CancerNetwork® spoke with Yoshie Umemura, MD, PhD, about her institution’s ongoing research efforts in the field of brain tumors.

Umemura, Chief Medical Officer, Division Chief of Neuro-Oncology at the Ivy Brain Tumor Center, and William and Joan Shapiro Professor of Neuro-Oncology at the Barrow Neurological Institute, highlighted the Phase 3 GlioFocus trial (NCT06388733), in which he and his collaborators are evaluating treatment with niraparib (Zejula) for patients with newly diagnosed MGMT-unmethylated glioblastoma. He further explained how the institution’s staff is leveraging certain multidisciplinary collaborations at the Ivy Brain Tumor Center to more quickly advance clinical trial efforts across phases compared to traditional approaches.

Transcript:

We are excited about the Phase 3 clinical trial that we are sponsoring right now. I am the principal investigator at the Ivy Brain Tumor Center site, and we are sponsoring this international trial as an institution. We are excited about the study itself, but I think what is most exciting is how it came to be. Phase 3 clinical trials often take years, sometimes more than a decade, to go from Phase 0, Phase 1, Phase 2 to Phase 3. It takes forever. Even starting one Phase 2/3 study can take years from talking about the concept to getting to the starting line.

Because we have a unique platform to leverage the multidisciplinary and creative talent we have here to safely eliminate red tape, we now have a platform in place that allows us to move from early to late phase quickly. We were able to move from phase 0 and phase 2 to a phase 3 international trial in just a few years. It’s exciting to have this platform and to have proven that it can be done, because it’s not just one drug or one trial that makes the difference. When you get a positive or negative result in one trial, it leads to a lot of follow-up questions and follow-up trials. We can’t take 15 to 30 years to answer one simple question. We need a platform that shows that we can do many trials safely and effectively and do them much faster than traditional methods. It’s very exciting.



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